Page 13 - CTPA Annual Report 2011

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10.
Parabens
2011 was an important year for the parabens, a family of
preservatives that most in our industry believe to be safe and
effective. The publication of the draft SCCS opinion in
December 2010 has been followed by a year of discussion
over how this opinion will be implemented into cosmetics
legislation. Not only were a number of regulatory proposals
discussed at the European Commission’s Working Group on
Cosmetics meetings over the course of the year, the SCCS
was also mandated to provide clarification regarding the use
of parabens in products for children. This was, in part, to
address actions by the Danish Authorities to ban propyl
and butyl parabens in cosmetic products for children under
three. Discussions will continue into 2012 although, based on
the positive SCCS opinions that support the safety of these
ingredients, we hope that a satisfactory resolution will be
arrived at soon.
D4/D5
The two cyclic siloxanes, D4 and D5, have received much
attention in 2011, both from a human health and environmental
perspective. For human health, since the publication of the SCCS
opinion in July 2010 concluding the safety of D4 and D5 under
current practices of use, discussions have been focussed on the
regulation of these materials under cosmetics legislation.
During the EC Working Group meeting in November, in light
of concerns from industry, it was agreed that industry would
provide updated usage information for D4. A further industry
dossier would also be prepared for the SCCS evaluation of D5
in its own right.
Both D4 and D5 are also receiving attention under REACH,
the culmination of a seven-year-long review of these ingredients
in the UK. It is up to the UK Competent Authority to propose
environmental risk management measures for each of these
substances. CTPA has been involved in representing the
European industry position to the various UK Government
Departments involved in the process (HSE, Defra, BIS). News of
the nature of the UK proposal is expected in mid 2012.
Ingredients activity in France
The French Agency, Afssaps, has been very active in 2011
performing its own risk assessments for a number of
cosmetic ingredients. As an outcome of this activity,
we have seen reports released on benzophenone-3,
aluminium and nano-form titanium dioxide and zinc oxide,
as well as a decision to ban 3-benzylidene camphor in
cosmetic products in France. We know that many other
ingredients are also receiving attention.
We understand that it is the intention of the French
Agency to share its reports or assessments with the
European Commission. It remains to be seen how
these reports will be received and if any will prompt
an SCCS evaluation. Industry continues to monitor the
situation and act where appropriate.
Nanomaterials
Following a prolonged period of consultation and discussion,
October 2011 saw the adoption of the European Commission’s
Recommendation on the Definition of Nanomaterials.
The Recommendation provides a broad regulatory definition
that affects all industry sectors within the EU. However, its
recitals do allow for the narrowing of the scope under specific
sector legislation. It is the industry position that both the
Recommendation and the definition in the Cosmetics Regulation
can co-exist. The Commission has also indicated that the criteria
in the Regulation definition are useful in narrowing its scope to
those materials that may be of concern. However, the possibility
is foreseen that criteria based on a size or a weight distribution
cut-off could eventually be introduced into the definition in the
Cosmetics Regulation.
The Commission has so far provided no interpretation of
the Cosmetics Regulation definition criteria. Mindful of
the 2013 deadlines for compliance with the Cosmetics
Regulation’s requirements for nanomaterials (labelling and
notification), our European association, Cosmetics Europe,
has released the industry interpretation of the definition to
its Members as guidance. Companies are now committing
resources to meet the requirements of the regulation but
based on our own industry’s interpretation of the official
definition of a nanomaterial.
Tooth whitening
After more than 10 years of discussion, the European Council
adopted a directive in September 2011 that allowed tooth
whitening products with higher levels of hydrogen peroxide.
Although this type of product has been available overseas for
many years, and there have been a number of safety reviews,
the Member States of the EU could never agree on the controls
necessary to introduce these products to the EU market.
Consequently, the normal legal process of European Commission
and working groups, made up of officials from all EU countries,
agreeing a regulatory proposal has been overridden in this case.
Although this mechanism is rarely used, perhaps even more
unusual is that, for the first time, the way a cosmetic product
is sold has been regulated; these tooth-whitening toothpastes
can only be made available to consumers after a consultation
with a dentist.